Application of Telemedicine to the Management of Aggressive Lymphomas

Lymphoma Clinical Trial

— AMA  

Official title:

Application of Telemedicine to the Management of Aggressive Lymphomas: a Regional Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03336138
• Other study ID #: RC31/12/0072
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: January 31, 2019

Study information

• Verified date: April 2019
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the value of AMA in a comparative multicenter regional study as a reference for aggressive lymphoma. The primary endpoint will be RDI. This study consider that the AMA support should allow a significant improvement of the RDI compared to the control group and thus impact the duration without progression. The study covers 350 patients recruited from 10 regional centers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patient with a recent diffuse large B cell lymphoma (LBDGC), histologically proven, with treatment not started

• a priori likely to be treated by rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone every 21 days (R-CHOP21) for 8 cycles or rituximab, doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone (R-ACVBP).

• Index international prognosis (IPI) measurable (IPI-aa), adjusted for age. Any IPI-aa is eligible.

• accepting the study

Exclusion Criteria:

• Patient with another type of lymphoma (including transformed follicular forms)

• Patient having already started his treatment.

• Life expectancy <3 months.

• Carcinologic history

• Serum positive for HIV or hepatitis B virus (HBV).

Related Conditions & MeSH terms

• Lymphoma

Intervention

Other:
• AMA (Assistance for ambulatory patients)
telephone follow-up modality

Locations

Country	Name	City	State
France	Clinique Claude Bernard	Albi
France	Hospital	Auch
France	Bayonne Hospital	Bayonne
France	University Hospital Bordeaux	Bordeaux
France	Hospital	Montauban
France	Clinique Marzet	Pau
France	Rodez Hospital	Rodez
France	Tarbes Hospital	Tarbes
France	Clinique Saint Jean	Toulouse
France	University Hospital of Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dose-relative intensity (RDI)	reduction of RDI	through study completion, an average of 2 years